Table 2.
Summary of ongoing and planned key durvalumab trials in early-stage bladder cancer, hepatocellular carcinoma and cervical cancer
| Diagnosis and staging | Setting | Trial | Patient population | Estimated (or actual) enrollment | Design | Primary end points |
|---|---|---|---|---|---|---|
| Resectable muscle-invasive bladder cancer | Neoadjuvant/ adjuvant | NIAGARA [111, 112] (NCT03732677) | Stage T2–T4aN0/1M0 with transitional and mixed transitional cell histology | 1050 |
Phase 3, open-label, randomized, global trial Arm 1: Neoadjuvant durvalumab + cisplatin-gemcitabine, with adjuvant durvalumab Arm 2: Neoadjuvant cisplatin-gemcitabine, with observation after surgery |
pCR EFS |
| Non-muscle invasive bladder cancer | BCG-naïve | POTOMAC [115, 116] (NCT03528694) | High riska | 973 |
Phase 3, open-label, randomized, global trial Arm 1: Durvalumab + BCG (induction and maintenance) Arm 2: Durvalumab + BCG (induction only) Arm 3: BCG (induction and maintenance) |
DFS |
| Locoregional hepatocellular carcinoma | TACE-naïve | EMERALD-1 [122, 123] (NCT03778957) | Not amenable to curative therapy | 600 |
Phase 3, double-blind, randomized, global trial Arm A: TACE + durvalumab Arm B: TACE + durvalumab + bevacizumab Arm C: TACE + placebo |
PFS (Arm B vs. Arm C) |
| Hepatocellular carcinoma | Adjuvant | EMERALD-2 [124, 125] (NCT03847428) | Prior curative resection or ablation and high risk of recurrence | 888 |
Phase 3, double-blind, randomized, global trial Arm A: Durvalumab + bevacizumab Arm B: Durvalumab Arm C: Placebo |
RFS (Arm B vs. Arm C) |
| Locally advanced cervical cancer | CRT-naïve | CALLA [128, 129] (NCT03830866) | Cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2–IIB node positive or FIGO (2009) Stages IIIA–IVA any node | 714 |
Phase 3, double-blind, randomized, global trial Arm 1: Durvalumab + SOC cCRT, followed by durvalumab Arm 2: Placebo + SOC cCRT |
PFS |
The current status of each trial (i.e., recruitment status and estimated primary completion date) can be obtained by accessing its study record on the ClinicalTrials.gov registry using its unique NCT number
BCG bacillus Calmette-Guerin, CIS carcinoma in situ, (c)CRT (concurrent) chemoradiotherapy, DFS disease-free survival, EFS event-free survival, FIGO International Federation of Gynecology and Obstetrics (staging system), G3 histologic grade 3, HCC hepatocellular carcinoma, MIBC muscle-invasive bladder cancer, NMIBC non-muscle-invasive bladder cancer, pCR pathologic complete response, PFS progression-free survival, RFS recurrence-free survival, RT radiation therapy, SOC standard of care, TACE transarterial chemoembolization
aDefined as any of the following: T1 tumor; high grade/G3 tumor; CIS; multiple, recurrent and large (i.e., diameter of largest evaluable node ≥ 3 cm; all three criteria must be met here) tumors